The U.S. Food and Drug Administration (FDA) announced on June 1, 2022, that Ukoniq (umbralisib; TG Therapeutics Inc.) is being withdrawn from the market due to safety concerns.
Ukoniq is a kinase inhibitor that was approved in 2021 for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least 1 prior anti-CD20-based regimen, and for relapsed or refractory follicular lymphoma who have received at least 3 prior lines of systemic therapy. These indications were approved under accelerated approval based on overall response rate; continued approval for these indications was contingent upon verification and description of clinical benefit in a confirmatory trial.
Updated findings from the UNITY-CLL trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits. Based upon this determination, the drug’s manufacturer announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in marginal zone lymphoma and follicular lymphoma.
The FDA is recommending that healthcare professionals should stop prescribing Ukoniq and switch patients to alternative treatments. Patients currently taking Ukoniq should be notified of the increased risk of death seen in the clinical trial, and advised to stop taking the medicine. In limited circumstances in which a patient may be receiving benefit from Ukoniq, the manufacturer plans to make it available under expanded access.
U.S. Food and Drug Administration (FDA). Ukoniq (umbralisib): Drug Safety Communication – FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns. June 1, 2022. Available at: click here. Accessed June 2, 2022.